When you make high-stakes products, you need confidence your teams are adhering to compliance or quality processes.
Jama lets teams focus on making great medical devices that drive value and improve quality of life. With Jama configured to your workflows and best practices, teams are empowered to spend more time on product development and less time on managing compliance processes and documentation.
Jama, combined with your organization’s quality process, can facilitate compliance with these regulations: 21CFR820, 21CFR11, ISO 13485, ISO 14971, IEC 62304, IEC 61508
Conduct reviews and approvals
Maintain the chain of approval and increase stakeholder participation. Within Jama, tie electronic signatures to specific reviews or baselines in compliance with 21 CFR Part 11. Learn more about Reviews & Approvals.
Design verification and validation
Seamlessly manage V-model traceability including test cases used for verification and validation, and provide evidence to comply with government regulations and standards, like 21 CFR Part 820. Read more about Test Management.
Maintain audit trails with reports
Customizable, real-time reporting and baselining allows you to track all changes to information within the system, including time-stamps and associated users. See more on Reporting.
By 2019, 25% of supply chain organizations collaborating on digital products and services will experience at least one product failure due to software defects and related cyber risks.Janet Suleski, Gartner Predicts 2016: Digital Business Will Disrupt Product Design, Manufacturing and PLM, 16 November 2015
This 5-minute overview illustrates how to use Jama to build a complex medical device that contains both hardware and software components.
Try Jama out for 30 days using the same dataset by activating your free trial.